Analgesia After Total Knee Replacement Surgery

Comparison of Intra-articular Infiltration and Gabapentin With Epidural Analgesia After Total Knee Replacement Surgery

Postoperative pain after total knee replacement surgery is difficult to treat. Mobilisation and hospital discharge might be delayed. Recent research shows that intra-articular infiltration with local anesthetics and perioperative prescription of gabapentin can improve outcome.

Objective of the study: Comparison of mobilisation speed and postoperative NRS-scores of patients after total knee replacement surgery which is treated with epidural analgesia or peroperative infiltration of the knee. Appraisal of the value of gabapentin for reduction of postoperative opiate consumption.

Study Overview

• Status: Completed
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Drug: marcaine; Drug: sufentanil; Drug: naropin; Drug: neurontin

Detailed Description

Study design:

Prospective randomised study

Study population:

Patients aged eighteen years or older, in whom knee replacement surgery is indicated. They will have spinal anaesthesia and epidural analgesia if indicated by randomisation. They must not have contraindications for epidural analgesia or the used medication in this study.

Intervention:

The first group will be treated with epidural analgesia. Before surgery the epidural catheter will be placed according to local guidelines. After the operation epidural infiltration with bupivacaine and sufentanil will be commenced. The second group will receive local infiltration with ropivacaine of the knee during surgery. Half of these patients will additionally be treated with gabapentin.

Primary study parameters/outcome of the study:

NRS-score (11-scale Numeric Rating Scale in which 0 means no pain, and 10 means most pain imaginable) in rest.

Secondary study parameters/outcome of the study:

Speed of mobilisation, postoperative opiate consumption. NRS scores during flexion exercise of the knee and during walking exercise.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Nieuwegein, Netherlands, 3430 EM
    • St. Antonius Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years or older and legally responsible
• Waiting for total knee replacement surgery
• Informed consent

Exclusion Criteria:

• Contraindications for epidural analgesia
• Aortic Valve stenosis
• Severely compromised cardiac function
• infection near epidural punction site
• Redo knee surgery
• Previous arthrotomies
• Allergy/Hypersensitivity for study mediation or all other used medication
• Participation in other studies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: epidural analgesia; The first group will be treated with epidural analgesia. Before surgery the epidural catheter will be placed according to local guidelines. After the operation epidural infiltration with bupivacaine and sufentanil will be commenced.	Drug: marcaine; bupivacaine 0,125%; Other Names: bupivacaine; Drug: sufentanil; sufentanil 1mcg/ml; Other Names: sufenta forte
ACTIVE_COMPARATOR: local infiltration; The second group will receive local infiltration with ropivacaine of the knee during surgery.	Drug: naropin; ropivacaine 0,2%, 3x 50 ml during surgery; Other Names: ropivacaine
ACTIVE_COMPARATOR: local infiltration and gabapentin; The third group will receive local infiltration with ropivacaine of the knee during surgery and will additionally be treated with gabapentin.	Drug: naropin; ropivacaine 0,2%, 3x 50 ml during surgery; Other Names: ropivacaine; Drug: neurontin; gabapentin 600 mg pre-operative 3 dd 300 mg; Other Names: gabapentin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
NRS score in rest	3 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speed of mobilisation		3 days after surgery
Postoperative morphine consumption	Daily morphine consumption (mg) per day	3 days after surgery
NRS score during flexion exercise		3 days after surgery
NRS score during walking exercise		3 days after surgery

Collaborators and Investigators

• Sponsor: St. Antonius Hospital
• Investigators: Principal Investigator: Leon Timmerman, MD, Anesthesiologist; Principal Investigator: Louis N Marting, MD, Orthopedic Surgeon

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: December 8, 2011
• First Submitted That Met QC Criteria: December 8, 2011
• First Posted (ESTIMATE): December 9, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 8, 2015
• Last Update Submitted That Met QC Criteria: June 4, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Arthroplasty; Knee; Epidural; Local infiltration
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Adjuvants, Anesthesia; Anti-Anxiety Agents; Anticonvulsants; Anesthetics, Local; Antimanic Agents; Gabapentin; Bupivacaine; Ropivacaine; Sufentanil
• Other Study ID Numbers: TKP-37796